Navigation Links
YM BIOSCIENCES PROVIDES EU REGULATORY UPDATE
Date:12/5/2008

MISSISSAUGA, ON, Dec. 5 /PRNewswire-FirstCall/ - YM BioSciences Inc. (NYSE Alternext US:YMI, TSX:YM, AIM:YMBA), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today reported that Oncoscience AG, the European licensee of nimotuzumab from YM's subsidiary, CIMYM BioSciences Inc., has withdrawn its application to the European Medicines Agency (EMEA) for marketing authorization of nimotuzumab. Withdrawal of an application does not prejudice the possibility of a company making a new application at a later stage.

The application for the marketing authorization for nimotuzumab was submitted to the EMEA on October 4th, 2007. At the time of the withdrawal it was under review by the Agency's Committee for Medicinal Products for Human Use (CHMP). In its official letter Oncoscience AG states that the withdrawal of the application was made 'because it was not able to adequately address the concerns of the CHMP regarding the quality and efficacy of the medicine within the required time schedule'.

"The questions from EMEA regarding the efficacy of nimotuzumab are based only on data submitted by Oncoscience AG from an unplanned, retrospective, subgroup analysis of a single arm, open label, monotherapy Phase II study of 47 patients with pediatric glioma. This analysis in no manner reflects on the overall efficacy of nimotuzumab, which already has been approved for marketing in twelve countries with efficacy demonstrated in numerous indications," said David Allan, Chairman and CEO of YM BioSciences. "We are very pleased that Oncoscience AG withdrew its application in anticipation of a later resubmission as this application was based on a very small sample that was not prospectively studied. We note that this withdrawal is consistent with actions taken by numerous large and development stage pharmaceutical companies under similar circumstances and we believe it was the correct means for managing th
'/>"/>

SOURCE YM BioSciences Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. CeloNova BioSciences Commercializes CATANIA(TM) Coronary Stent With NanoThin Polyzene(R)-F in Europe and Middle East
2. DuPont Applied BioSciences Selects MBI to Collaborate on Process Development and Scale-Up for New Bio-based Product
3. Ellen McDonald Joins Regado Biosciences as Senior Vice President of Business Operations and Chief Business Officer
4. Frost & Sullivan Recognizes Martek Biosciences for Unique and Customer-Focused Strategies With Customer Value Enhancement Award
5. Regado Biosciences to Present at the Piper Jaffray Health Care Conference on Tuesday, December 2, 2008
6. Sangamo BioSciences to Webcast Annual Investor and Analyst Briefing and Presentation at Piper Jaffray Health Care Conference
7. Cyntellect Appoints Former BD Biosciences Executive Andre Lubarsky as Director of Sales - North America
8. Neurocrine Biosciences to Present at the 20th Annual Piper Jaffray Health Care Conference
9. Sangamo BioSciences Appoints Paul Cleveland to Its Board of Directors and Chair of Audit Committee
10. BBM Announces Offer to Acquire YM BioSciences Inc.
11. Sangamo BioSciences Announces Results From Diabetic Neuropathy Clinical Trial SB-509-601
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... Selexis SA, a serial innovation company with ... used for drug discovery to commercial manufacturing, announced today ... Next-Generation Sequencing (NGS) data packages. The NGS analysis ... ensuring the integrity of the gene, validation of the ...
(Date:1/22/2015)...  Varian Medical Systems (NYSE: VAR ), world leader ... commitment to sustainability with inclusion on a prestigious list of ... healthcare equipment company among the Corporate Knights Global 100 Most ... at Davos, Switzerland . ...
(Date:12/24/2014)... 24, 2014  United Therapeutics Corporation (NASDAQ: UTHR ... MDT ) has submitted a pre-market approval application to ... use of Medtronic,s SynchroMed ® II implantable drug ... with United Therapeutics, Remodulin ® (treprostinil) Injection delivered ...
(Date:12/24/2014)... “Preparative & Process Chromatography Market by Instrument (Liquid ... Valves, Guages, Seals), Accessories, Services, End User (Biotechnology, ... provides a detailed overview of the major drivers, ... impacting the preparative and process chromatography market along ...
Breaking Biology Technology:Selexis Generated Research Cell Banks Now Fully Sequenced Using Next-Generation Sequencing 2Varian Honored Among World's 100 Most Sustainable Corporations 2United Therapeutics Announces Submission Of Pre-Market Approval Application For Implantable Drug Infusion System To Deliver Remodulin 2United Therapeutics Announces Submission Of Pre-Market Approval Application For Implantable Drug Infusion System To Deliver Remodulin 3United Therapeutics Announces Submission Of Pre-Market Approval Application For Implantable Drug Infusion System To Deliver Remodulin 4Preparative and Process Chromatography Market is expected to reach $9 billion by 2019 - New Report by Marketsandmarkets 2Preparative and Process Chromatography Market is expected to reach $9 billion by 2019 - New Report by Marketsandmarkets 3Preparative and Process Chromatography Market is expected to reach $9 billion by 2019 - New Report by Marketsandmarkets 4
... MONICA, Calif., April 30 Cord Blood America, Inc. ... cell preservation company ( http://www.cordblood-america.com ... stem cells to families nationwide and internationally, today said ... Jackie Speier (D-CA.) that would require the Secretary of ...
... Neurologic Safety following Treatment with Qutenza(TM) (NGX-4010)Identification of ... CostsSAN MATEO, Calif., April 29 /PRNewswire-FirstCall/ -- ... a biopharmaceutical company focused on developing and commercializing ... of two posters at the 61st Annual American ...
... April 29 Orchid Cellmark Inc., (Nasdaq: ... and Chief Executive Officer of Orchid Cellmark, is scheduled to ... in New York City on Wednesday, May 13, 2008 at ... and discuss the company,s recent and ongoing progress. A link ...
Cached Biology Technology:Cord Blood America Supports Effort in Congress to Inform on Value of Umbilical Cord Blood Stem Cell Storage 2NeurogesX Presents Two Posters at 61st Annual American Academy of Neurology Annual Meeting 2NeurogesX Presents Two Posters at 61st Annual American Academy of Neurology Annual Meeting 3NeurogesX Presents Two Posters at 61st Annual American Academy of Neurology Annual Meeting 4NeurogesX Presents Two Posters at 61st Annual American Academy of Neurology Annual Meeting 5Orchid Cellmark to Present at the 2009 Bank of America Health Care Conference on May 13th 2Orchid Cellmark to Present at the 2009 Bank of America Health Care Conference on May 13th 3
(Date:12/17/2014)... 2014 The Defense Logistics Agency is insourcing its ... counterfeit microcircuits from entering into its supply chain. ... anti-counterfeit initiative dubbed DNA marking. The capability will validate ... throughout the supply chain. The new quality control measures ...
(Date:12/17/2014)... , Dec. 16, 2014 Valencell, a leader ... PerformTek biometric technology to industry leaders such as Intel, ... clinically validated, biometric wearable products. These products will be ... Las Vegas . ...
(Date:12/17/2014)... DENVER , Dec. 16, 2014  Automation is fundamentally ... evident than at international borders. Over the past decade, ... veteran travelers to self process through border control via ... increasing number of airports, seaports, and land borders across ...
Breaking Biology News(10 mins):Defense Logistics Agency Launches DNA Marking Capability to Strengthen Microcircuit Supply Chain 2Defense Logistics Agency Launches DNA Marking Capability to Strengthen Microcircuit Supply Chain 3Valencell PerformTek Biometrics Power the Most Accurate Wearables at CES 2015 2Automated Border Control (ABC) Transforms the Global Travel Experience With More Than 2500 ABC eGates and APC Kiosks Deployed In Airports, Seaports, and Land Borders Worldwide 2
... tool, Johns Hopkins scientists report that they have refined a ... sending them to exact locations at precise times. ... ever in manipulating single molecules, allowing them to see how ... to determine whether cells will grow, die, move or divide. ...
... Spanish . U.S. Department of Agriculture ... for methyl bromide are studying an alternative soil treatment that ... USDA,s Agricultural Research Service (ARS) are examining whether a cropping ... used to replace the popular fumigant. They also are studying ...
... cells and then clicking off the light makes the cells ... for chemotherapy drugs, as well as a non-invasive way to ... a report in ACS,s The Journal of Physical Chemistry ... colleagues note using this technique before to force cancer cells ...
Cached Biology News:Hopkins researchers use light to move molecules 2Alternatives eyed for methyl bromide 2
PTFE/red rubber septum silver aluminum seal ,11 mm seal diam. ...
... enzyme that catalyzes the conversion,of starch ... maltotriose and,dextrins. The level of a-amylase ... are of clinical importance,1-3 while plant ... industry.4, The EnzChek Amylase Assay Kit ...
Rat monoclonal [20d5] to NKG2A + C+ E ( Abpromise for all tested applications). Antigen: Tissue / cell preparation (Mouse): CHO transfected cells expressing the B6 allele of NKG2A. Entrez Gen...
... FL is equipped with ... measurement technologies that complement ... advanced features of Fluoroskan ... Fluoroskan Ascent FL provides ...
Biology Products: